Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 14701–14720 of 38,428 recalls
Recalled Item: Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product
The Issue: Breaking at the point of a welded joint
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthopedics 6.0MM ROD
The Issue: Product may have incorrect laser etched alignment lines,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product
The Issue: Breaking at the point of a welded joint
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product
The Issue: Breaking at the point of a welded joint
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product...
The Issue: Breaking at the point of a welded joint
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product
The Issue: Breaking at the point of a welded joint
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product
The Issue: Breaking at the point of a welded joint
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product
The Issue: Breaking at the point of a welded joint
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage:
The Issue: Insufficient amount of antibody without an error message
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DYNEX Agility
The Issue: Control samples aspirated from wrong SmartKit on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1
The Issue: The rivets that secure the elastic headband to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6' (15 cm) Appx 0.09 ml
The Issue: Incorrect filter assemblies in IV administration set
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
The Issue: Baxter is updating the device IFU for safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
The Issue: Baxter is updating the device IFU for safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectrum IQ Infusion System with Dose IQ Safety Software
The Issue: Baxter is updating the device IFU for safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
The Issue: Baxter is updating the device IFU for safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Syringe Module Model 8110 - Product Usage: is intended
The Issue: LED display, which provides infusion or patient monitoring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump Module Model 8100 - Product Usage: is intended
The Issue: LED display, which provides infusion or patient monitoring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris SpO2 Module Model 8210 and Model 8220 - Product
The Issue: LED display, which provides infusion or patient monitoring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris EtCO2 Module Model 8300 - Product Usage: is intended
The Issue: LED display, which provides infusion or patient monitoring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.